HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.

Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.

Drug: raltegravir

This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.

Other Name: MK-0518, Isentress

Detailed Description:

Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study.

Subject is ≥ 18 years of age and able to understand and willing to sign a written informed consent form, which must be obtained prior to initiation of the study.

Currently receiving a stable antiretroviral regimen consisting of enfuvirtide plus at least 2 other antiretrovirals for at least 6 months.

Negative serum pregnancy test (females of childbearing potential only) and are willing to use an adequate method of contraception throughout the duration of the study.

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not to be enrolled in this study.

Any prior therapy with MK-0518 or any other HIV-1 integrase inhibitor.

Any HIV-1 viral load > 75 copies/ml by bDNA assay, or > 50 copies/ml by Ultrasensitive PCR assay in the 6 months prior to screening visit (A single "blip" of HIV-1 viral load >75 copies but <400 copies by bDNA assay, or >50 copies but <400 copies by Ultrasensitive PCR assay in the six months prior to screening visit with at least one subsequent HIV-1 viral load below the limit of detection will be accepted.)

Any previous known hypersensitivity to components of the study drug formulation.

Weight < 40 kilograms.

Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.

Acute therapy for serious illness (in the opinion of the investigator) within 14 days prior to study entry unless the subject has completed ≥ 7 days of therapy and is considered clinically stable by the investigator.

Any condition which, in the opinion of the investigator, would compromise the subject's ability to participate in the study.

Any active opportunistic infections or Centers for Disease Control and Prevention (CDC) Category C conditions (with the exception of stable cutaneous Kaposi's Sarcoma and wasting syndrome due to HIV infection).

Female patient who is pregnant or breast-feeding, or expecting to conceive or donate eggs during the study. Male patient who is planning to impregnate or provide sperm donation during the study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529243